The evolving use of biomarkers in heart transplantation: Consensus of an expert panel

Kobashigawa, Jon A.; Hall, Shelley; Shah, Palak; Fine, Barry; Halloran, Philip F.; Jackson, Annette M.; Khush, Kiran K.; Margulies, Kenneth B.; Sani, Maryam Mojarrad; Patel, Jignesh; Patel, N.; Peyster, Eliot

doi:10.1016/j.ajt.2023.02.025

Cited by 14 publications

(8 citation statements)

References 46 publications

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“…A large multicenter study found a strong correlation between dd-cfDNA and rejection and also demonstrated a rise in dd-cfDNA before the occurrence of biopsy-proven rejection and a drop following the treatment of rejection, findings that suggest the potential clinical utility of this biomarker [42]. As a result of these findings, the latest guidelines from the International Society for Heart and Lung Transplantation support the use of dd-cfDNA as a useful non-invasive biomarker to monitor and detect allograft rejection [43,44].…”

Section: Discussionmentioning

confidence: 78%

Ten-Year Experience with Endomyocardial Biopsy after Orthotopic Heart Transplantation: Comparison between Trans-Jugular and Trans-Femoral Approach

Galeone,

Bernabei,

Pesarini

et al. 2024

JCDD

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Background: Endomyocardial biopsy (EMB) is considered the gold standard for monitoring allograft rejection after heart transplantation. EMB is an invasive procedure that may be performed via a trans-jugular or a trans-femoral approach with a complication rate reported as less than 6%. The aim of this study was to evaluate the complication rate after EMBs in heart recipients and to compare the results of EMBs performed via a trans-jugular or a trans-femoral approach. Methods: Medical records of heart recipients undergoing EMBs between January 2012 and December 2022 were retrospectively reviewed. EMB-related complications were classified as major (death, pericardial effusion, hemopericardium, cardiac tamponade requiring a pericardiocentesis or an urgent cardiac surgery, ventricular arrythmias, permanent atrio-ventricular block requiring permanent pacing, hemothorax, pneumothorax and retroperitoneal bleeding) and minor (de novo tricuspid regurgitation, arrhythmias, coronary artery fistula, vascular access site complications). Results: A total of 1698 EMBs were performed during the study period at our institution in 212 heart recipients. There were 927 (55%) EMBs performed through a trans-jugular approach (TJ group) and 771 (45%) EMBs performed through a trans-femoral approach (TF group). A total of 60 (3.5%) complications were recorded, including nine (0.5%) major complications (six cardiac tamponades, two pneumothorax and one retroperitoneal bleeding) and 51 (3%) minor complications (seven coronary fistulae, five de novo tricuspid regurgitation, four supraventricular arrythmias and thirty-five vascular access site complications). No difference was found in total (38 [4%] vs. 22 [3%]; p = 0.16) and major (6 [1%} vs. 3 [0.4%]; p = 0.65) complications (32 [3%] vs. 19 [2%]; p = 0.23) between the TJ group and the TF group. No difference was found in male sex, age at time of EMB and time from HT between complicated and not complicated EMBs. Conclusions: EMBs represent a safe procedure with a low risk of complications. In our experience, EMBs performed via a trans-jugular approach are as safe as the trans-femoral approach.

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Section: Discussionmentioning

confidence: 78%

Ten-Year Experience with Endomyocardial Biopsy after Orthotopic Heart Transplantation: Comparison between Trans-Jugular and Trans-Femoral Approach

Galeone,

Bernabei,

Pesarini

et al. 2024

JCDD

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“…Additional biomarkers include microribonucleic acids (miRNA) and extracellular vesicles. 57 miRNA are highly stable molecules that regulate gene expression, and in one study had a favorable AUC to identify HT rejection. 58,59 Extracellular vesicles are circulating vesicles in blood containing cells from multiple sites in the body, including a donor heart.…”

Section: Cardiac Magnetic Resonance Imaging (Cmr)mentioning

confidence: 99%

“…Additional biomarkers include microribonucleic acids (miRNA) and extracellular vesicles 57 . miRNA are highly stable molecules that regulate gene expression, and in one study had a favorable AUC to identify HT rejection 58,59 .…”

Section: Future Directionsmentioning

confidence: 99%

The utilization of molecular microscope in management of heart transplant recipients in the era of noninvasive monitoring

Mehlman,

Valledor,

Moeller

et al. 2023

Clinical Transplantation

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IntroductionMonitoring for graft rejection is a fundamental tenet of post‐transplant follow‐up. In heart transplantation (HT) in particular, rejection has been traditionally assessed with endomyocardial biopsy (EMB). EMB has potential complications and noted limitations, including interobserver variability in interpretation. Additional tests, such as basic cardiac biomarkers, cardiac imaging, gene expression profiling (GEP) scores, donor‐derived cell‐free DNA (dd‐cfDNA) and the novel molecular microscope diagnostic system (MMDx) have become critical tools in rejection surveillance beyond standard EMB.MethodsThis paper describes an illustrative case followed by a review of MMDx within the context of other noninvasive screening modalities for rejection.ConclusionsWe suggest MMDx be used to assist with early detection of rejection in cases of discordance between EMB and other noninvasive studies.

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“…Donor-derived cell-free DNA (dd-cfDNA) from peripheral blood has received growing attention as a biomarker of HTx rejection and has been suggested for possible use for AR surveillance by the International Society for Heart and Lung Transplantation (ISHLT) and the American Society of Transplantation (AST). 3 , 4 Cardiomyocytes damaged from AR release circulating DNA into the bloodstream that can now be measured to a high degree of sensitivity. Correlation between increased dd-cfDNA levels and AR was first shown by Snyder and colleagues using shotgun whole-genome sequencing.…”

Section: Introductionmentioning

confidence: 99%

Comparison of two donor‐derived cell‐free DNA tests and a blood gene‐expression profile test in heart transplantation

Rodgers

Gerding

Cusi

et al. 2023

Clinical Transplantation

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Background Donor‐derived cell‐free DNA (dd‐cfDNA) testing is an emerging screening modality for noninvasive detection of acute rejection (AR). This study compared the testing accuracy for AR of two commercially available dd‐cfDNA and gene‐expression profiling (GEP) testing in heart transplant (HTx) recipients. Methods This is a retrospective, observational study of HTx only patients who underwent standard and expanded single nucleotide polymorphism (SNP) dd‐cfDNA between October 2020 to January 2022. Comparison with GEP was also performed. Assays were compared for correlation, accurate classification, and prediction for AR. Results A total of 428 samples from 112 unique HTx patients were used for the study. A positive standard SNP correlated with the expanded SNP assay (p < .001). Both standard and expanded SNP tests showed low sensitivity (39%, p = 1.0) but high specificity (82% and 84%, p = 1.0) for AR. GEP did not improve sensitivity and showed worse specificity (p < .001) compared to standard dd‐cfDNA. Conclusion We found no significant difference between standard and expanded SNP assays in detecting AR. We show improved specificity without change in sensitivity using dd‐cfDNA in place of GEP testing. Prospective controlled studies to address how to best implement dd‐cfDNA testing into clinical practice are needed.

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The evolving use of biomarkers in heart transplantation: Consensus of an expert panel

Cited by 14 publications

References 46 publications

Ten-Year Experience with Endomyocardial Biopsy after Orthotopic Heart Transplantation: Comparison between Trans-Jugular and Trans-Femoral Approach

Ten-Year Experience with Endomyocardial Biopsy after Orthotopic Heart Transplantation: Comparison between Trans-Jugular and Trans-Femoral Approach

The utilization of molecular microscope in management of heart transplant recipients in the era of noninvasive monitoring

Comparison of two donor‐derived cell‐free DNA tests and a blood gene‐expression profile test in heart transplantation

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